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Arch_Investor

01/21/21 1:42 PM

#135057 RE: SC8 #135056

Foreign objects being left in the body can case complications....a gel that breaks down is much safer.....that is straightforward.....you are looking and searching for too many IF's against this product IMO
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Arch_Investor

01/21/21 1:44 PM

#135058 RE: SC8 #135056

By all means I'm not saying your wrong....and I do agree with your standpoint on a negative outcome.....but I still think it would be successful.....either way IDE is upon us doesn't matter STeP or not
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RUMe2

01/21/21 1:57 PM

#135062 RE: SC8 #135056

But the funny thing is the phrases "reasonably" and "significantly."

These two terms seem to cancel each other out? Because everyone seems to be in agreement, IF applied correctly, the improvement is significant. But, if something goes wrong, then possible safety concerns.

So, STeP approval could hinge on the word "reasonable." Is it unreasonable to expect, through provider training of product administration, radiogel could be a safely administered, standardized procedure (procedure-to-procedure)?